OP0161 24 MONTH RESULTS ON EFFECTIVENESS AND SAFETY OF A COMPARATIVE STUDY OF TOCILIZUMAB VERSUS TUMOUR NECROSIS FACTOR INHIBITION IN POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS
Authors: G. Horneff, A. Zimmer, T. Hospach, F. Weller-Heinemann, J. Kuemmerle-Deschner, M. Fasshauer, K. Minden, I. Foeldvari, D. Windschall, M. Hufnagel, D. Foell, P. Oommen, A. Klein
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Objectives</h3> To evaluate 24-month effectiveness and tolerability/safety of tocilizumab (TCZ) versus tumour necrosis factor inhibitor (TNFi), analysing predictors of JADAS remission and minimal disease activity (MDA), comparing 1<sup>st</sup> and 2<sup>nd</sup> line TCZ. <h3>Methods</h3> BIKER WA 29358 is a 5-year multi-centre prospective, observational cohort study including polyarticular juvenile idiopathic arthritis (JIA) patients in Germany starting treatment between 2015 and 2020 with TCZ and matched patients starting an approved TNFi such as etanercept, adalimumab or golimumab. Clinical disease activity (JADAS), JADAS MDA/remission at 24 months, safety and drug adherence were assessed and compared between cohorts. <h3>Results</h3> The analysis set consisted of 342 participants with 24-month treatment data (TCZ, n=171; TNFi, n=171) (Table 1). Therefore, patients starting on TCZ were older and had a longer disease duration compared to TNFi patients. Efficacy was demonstrated by a marked and comparable decrease of the JADAS10 in upon both TCZ and TNFi from 14.6+/-6.6 and 14.6+/-6.2 at baseline to 2.5+/-3.4 and 2.7+/-3.6 at month 24. TCZ was used as 2nd line biologic in the majority of patients (84%) while TNFi were mostly 1<sup>st</sup> line biologics (86%). In the last observation carried forward analysis, at 24 month JADAS remission upon TCZ/TNFi treatment was achieved by 84.6%/76.9% in 1<sup>st</sup> line biologic users and 62.3/66.7% in 2<sup>nd</sup> line users. JADAS MDA was achieved in 100%/87.9% in 1<sup>st</sup> line and 84.4%/91.7% in 2<sup>nd</sup> line users of TCZ/TNFi. After 24 months of treatment residual disease activity as measured by the JADAS10 (mean +/SD) was lower in the 1<sup>st</sup> line TCZ cohort compared to the 2<sup>nd</sup> line (1.0+/-1.2 vs. 2.7+/-3.6), while in the TNFi cohort residual JADAS10 was comparable in 1<sup>st</sup> or 2<sup>nd</sup> line (2.7+/-3.8 vs. 2.5+/-2.6). Safety was assessed based on adverse events reporting. 113 (66%) patients in the TCZ cohort and 105 (61%) patients in the TNFi cohort reported adverse events with a higher rate in the TCZ cohort (89 vs. 73/100 patient years (PY), RR 1.2 (95%CI 1.0-1.5), p=0.029, Wald-test) as well as the rate of serious adverse events (10 vs. 3/100 PY; p=0.045). Cytopenias were more common in the TCZ cohort (13 vs. 1; p=0.010) and injection site reactions were more common in the TNFi cohort (13 vs. 6/100 PY, p=0.089). There was no case of death and no opportunistic infection. In the TCZ/TNFi cohorts, 71 (42%)/72 (42%) patients discontinued treatment, 43/30 due to lack of efficacy, 14/22 due to remission and 7/6 due to intolerance, respectively. <h3>Conclusion</h3> In this interim analysis, treatment targets were reached with similar frequency after 24 months of treatment with TCZ or TNFi. TCZ was used predominantly as 2<sup>nd</sup> line biologic. Higher rates of remission and minimal disease activity were observed in 1<sup>st</sup> line compared to 2<sup>nd</sup> line TCZ users. More adverse events were reported in the TCZ cohort but no new safety signals were noted. Observation is ongoing. <h3>REFERENCES:</h3> NIL. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> Gerd Horneff Speakers bureau: Chugai, Pfizer, Novartis, Sobi, Grant/research support from: Novartis, Roche, Angela Zimmer: None declared, Toni Hospach: None declared, Fraank Weller-Heinemann: None declared, Jasmin Kuemmerle-Deschner Speakers bureau: Novartis, Grant/research support from: Novartis, Maria Fasshauer: None declared, Kirsten Minden Grant/research support from: Chugai, Roche, Ivan Foeldvari: None declared, Daniel Windschall: None declared, Markus Hufnagel: None declared, Dirk Foell Grant/research support from: Novartis, Prasad Oommen: None declared, Ariane Klein: None declared.